Kornimate/medical-research-clean huggingface dataset:
randomized comparison of combination azithromycin and hydroxychloroquine vs. hydroxychloroquine alone for the treatment of confirmed covid-19

Conditions: SARS-CoV-2; COVID-19

Summary: this is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous day 1-6 supportive care control, in eliminating detectable sars-cov-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.

primary objective: i. determine change in viral load at day 6 compared to baseline between two regimens to treat covid-19 and a contemporaneous control group. secondary objectives: i. time to resolution of symptoms (symptom questionnaire) ii. change in the fever curve resulting in shorter time to afebrile for 48 hours iii. normalization of vital signs iv. time to discharge (if hospitalized) v. assessment of agent toxicity as measured by standard metrics vi. collection of throat swab and blood for viral load, presence of igm or igg antibodies vii. if feasible on samples collected for quantitative pcr decrease in virus shedding (in oropharyngeal secretions) viii. measures of cytokines in blood including il6, il-8, tnf, inf ix. routine standard of care labs obtained as part of the care of these patients such as differential white count, crp, troponin and lfts will be analyzed for correlative trends

Eligibility criteria:
inclusion criteria: * patients with proven sars-cov-2 infection by an accepted assay with symptoms consistent with covid-19 * ability to measure and quantify viral load by quantitative pcr * age 18 to 89 * ability to swallow oral medications * patients must read, understand and sign irb approved informed consent exclusion criteria: * pregnancy or women who are breast feeding * two consecutive negative assays for sars-cov-2 infection * patients that lack decision-making capacity will not be approached to participate in this study * inability to tolerate oral medications * allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate * qtc interval \> 470 msec * history of ongoing ventricular cardiac dysrhythmias of grade 2 as described by nci ctcae 5.0 criteria * history of serious ventricular arrhythmia (vt or vf \> 3 beats in a row)
influence of ribavirin and interferon on semen quality, iris study

Conditions: Sperm Motility (Focus of Study)

Summary: the aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.

during and six months after treatment with peginterferon alpha and ribavirin strict use of birth control is recommended (the producers advice two reliable forms) for both men and women because ribavirin has teratogenic and/or embryo-lethal effects in animal studies. in cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. however three cases of births after paternal exposure are reported with no birth defects. cases of abnormalities after paternal exposure to ribavirin are lacking. also studies on the influence of ribavirin on sperm in human are lacking. the aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.

Eligibility criteria:
inclusion criteria: * written informed consent * treatment with peginterferon and ribavirin in the presence of a chronic hepatitis c infection exclusion criteria: * preexisting semen abnormalities. * concurrent use of drugs influencing sperm concentration,motility and morphology. * less then one million spermatozoa/ml in semen at screening.

Keywords: sperm chromatin structure integrity sperm concentration sperm motility sperm morphology peginterferon ribavirin hepatitis c
use of machine learning techniques for serial assessment of systemic inflammatory markers in breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer in women globally, with 2.3 million new cases diagnosed in 2020. hormone receptor positive (hr+), human epidermal growth factor receptor 2 negative (her2-) breast cancer is the most prevalent subtype, comprising 69% of all breast cancers in the usa. within the tumor immune microenvironment, a higher intensity of myeloid cell infiltration and low levels of lymphocyte infiltration have been associated with worse outcomes. markers in peripheral blood have emerged as predictive biomarkers that can be easily obtained non-invasively and at low cost. experiments have confirmed the relative components of these tests (such as the immune cells) directly or indirectly participated in tumour occurrence, development, and immune escape, underscoring the potential use of laboratory tests as tumour biomarkers

in breast cancer, increased neutrophil levels and decreased lymphocyte levels in peripheral blood are associated with worse overall survival (os). in hr+, her2- metastatic breast cancers, low pretreatment nlr and high pretreatment absolute lymphocyte count (alc) were related with better progression-free survival (pfs) and os. the development of predictive models, based on machine learning (ml) algorithms it has been used in prognostication and assist in the diagnosis of different types of cancer. although regular laboratory tests have potential to be breast cancer biomarkers, a single test is yet to provide adequate sensitivity or specificity. artificial intelligence (ai) could help with integrating data from multiple tests to aid diagnosis. technical improvements such as data storage capacity, computing power, and better algorithms mean that ml can process clinically meaningful information from laboratory test data. models' generalisability and stability still need to be confirmed, in view of limitations such as the absence of various pathological types, small cohorts, and lack of external validation. therefore, a competitive model is also essential to achieve more accurate stratification of patients with breast cancer. the purpose of this retrospective multicentre study is to systematically evaluate the ability of laboratory tests to predict breast cancer, and develop a robust and generalisable model to assist in identifying patients with breast cancer.

Eligibility criteria:
inclusion criteria: * women patients with age between 18 and 75 years old; * invasive breast carcinoma patients diagnosed by pathology ; * patients diagnosed between 1 january 2013 and 31 december 2018; * have a complete blood count performed before the surgical intervention (mastectomy or conservative breast surgery) or neoadjuvant chemotherapy; exclusion criteria: presence of hematological disorders; * bilateral breast cancer; * male; * karnofsky performance status score \< 70'; * inflammatory breast cancer and in situ carcinoma; * pregnancy or breastfeeding; * evidence of local or distant recurrence.

Keywords: breast cancer machine learning prognosis inflammation
evaluation of the safety and the efficacy of transanal tme in difficult cases

Conditions: Rectal Cancer

Summary: the purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case. difficult case is defined as below; - if any one of the following (1 or 2 or 3) 1. bmi: 30 or more 2. tumor size: more than 7cm in long diameter 3. crm: mesorectal fascia involvement or less than 1 mm on mri

subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. transanal visualization will be using endoscopy. at the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria:
inclusion criteria: * age: 20-80 years * biopsy-proven adenocarcinoma of the rectum * clinical staging (c or yc): t0-3, n0-2, m0 * rectal cancer located 3-12 cm from the anal verge * ecog performance status: 2 or less * if any one of the following (1 or 2 or 3) 1. bmi: 30 or more 2. tumor size: more than 7cm in long diameter 3. crm: mesorectal fascia involvement or less than 1 mm on mri exclusion criteria: * synchronous colon cancer or other malignancy * obstructing rectal cancer * pregnant or breast-feeding * receiving any other study agents * fecal incontinence * history of prior colorectal cancer or inflammatory bowel disease

Keywords: trananal tme safety efficacy difficult cases
three new methods for diagnosing pancreas cancer

Conditions: Pancreas Cancer

Summary: the purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. the investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones secretin and cholecystokinin, which triggers the enzyme production of pancreas. the hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. the investigators hope to be able to use this effect diagnostically. the patients included will also have a 64-slice-ct in order to evaluate, if an increased diagnostic safety can be reached compared to an older ct scanning method. all patients will also be examined for the tumor marker ca 19-9. further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.


Eligibility criteria:
inclusion criteria: * suspicion of cancer of the pancreas
a study of dulaglutide in japanese participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this trial is to examine the efficacy and safety of once-weekly ly2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (oam).

rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \[oam\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.

Eligibility criteria:
inclusion criteria: * participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening * participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). the dose of the drug(s) during the 8 weeks before screening must be stable * participants who have a qualifying glycosylated hemoglobin (hba1c) value of 7.0% to 10.0% at screening * participants who have a body mass index (bmi) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) exclusion criteria: * participants who have a diagnosis of type 1 diabetes * participants who have previously been treated with any other glucagon-like peptide 1 (glp-1) analog * participants who have received therapy with an alpha-glucosidase inhibitor (a-gi), thiazolidinedione (tzd), glinide, or dipeptidyl peptidase-iv (dpp-iv) inhibitor within 3 months before screening * participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening * participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening * participants who have self or family history of medullary c-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (mtc)

Keywords: glucagon-like peptide-1 (glp-1)
perioperative tpn improves surgical outcomes

Conditions: Parenteral Nutrition; Major Surgery; Malnutrition

Summary: preoperative optimization of patients is a well known concept. not all patients can tolerate feeds and as such tpn is given. tpn given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. so the investigators aim to find the impact of tpn in malnutritional surgical patients.

any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative tpn for 5 days. after 5 days, elective surgery was done and tpn was continued postoperatively until patient could consume 50% of their daily requirements orally. patients who underwent emergency surgeries were also enrolled in this study as these patients could receive tpn only postoperatively. daily patient charting with clavien dindo classification, length of stay and mortality were mentioned and verified by the operating surgical team. data was maintained electronically by the surgical team. data was also entered in ms-excel at the time of patient discharge. since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data. upon completion of study, all data will be exported to spss and analyzed accordingly using means, sds, chi-square and fisher exact test.

Eligibility criteria:
inclusion criteria: * 1. all patients who underwent major gastrointestinal surgery and received perioperative tpn or postoperative tpn exclusion criteria: * perioperative tpn administration that did not follow the study protocol * tpn given for reasons other than malnutrition

Keywords: parenteral nutrition tpn major surgery malnutrition in surgery clavien-dindo classification
bright light therapy for depression symptoms in adults with cystic fibrosis (cf) and copd

Conditions: Cystic Fibrosis; Depressive Symptoms; Chronic Obstructive Pulmonary Disease

Summary: this is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with cf and copd. the purpose of this project is to apply a daily 30-minute blt intervention to hospitalized adult cf and copd patients in order to decrease symptoms of depression as measured by depression inventory scoring.

this project will occur on a 29-bed pulmonary step-down unit at a 1,600-bed academic medical center. this unit commonly treats patients with cf, copd, and other pulmonary complications. the unit's patient care staff will be educated on the bright light lamps in order to prevent interruptions and to encourage compliance.

Eligibility criteria:
inclusion criteria: * diagnosed with cystic fibrosis or chronic obstructive pulmonary disease (copd) * adult age 18 or older * admitted to the pulmonary step-down and transplant unit * score greater than zero on pre-intervention beck's depression inventory-ii (bdi-ii) exclusion criteria: * pre-existing ophthalmological conditions or photosensitivity * migraines * receiving high dose steroids for transplant rejection (due to mood altering qualities), * antibiotics that increase light sensitivity * diagnosed with bipolar disorder (light therapy may trigger mania) * admissions anticipated to span less than 48 hours * children are being excluded due to the fact that only adult cf and copd subjects are admitted to university of pittsburgh medical center (upmc) presbyterian hospital

Keywords: cystic fibrosis depression bright light therapy adult copd
a cognitive behavioral therapy group intervention to increase hiv testing and prep use among latinx sexual minority men

Conditions: HIV

Summary: this study consists of a randomized controlled trial (rct) of a multi-session cognitive behavior therapy (cbt) group intervention that aims to improve hiv outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, hiv status, and prep use among latinx sexual minority men (smm).

this study consists of a randomized controlled trial (rct) of a multi-session cognitive behavior therapy (cbt) group intervention that aims to improve hiv outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, hiv status, and prep use among latinx sexual minority men (smm). we will test intervention effects on regular hiv testing and use of prevention strategies. the intervention was developed in partnership with community stakeholders at bienestar human services, inc., a latinx-focused organization in los angeles county (lac), ca. the intervention is flexible for use in community-based organizations, such as in ongoing support groups. the specific aims are: aim 1. to conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant latinx sexual minority men, to test intervention effects on regular hiv testing and prep uptake. aim 2. to examine mechanisms of intervention effects on regular hiv testing and prep uptake, including more effective coping (e.g., reduced internalized stigma). aim 3. to conduct a cost-effectiveness analysis of the intervention.

Eligibility criteria:
inclusion criteria: * at least 18 years-old * biologically male at birth * identify as male * identify as latino * is an immigrant * report having sex with men in the past 12 months * report hiv-negative or unknown serostatus * anticipate being available for the next 12 months to attend study visits * able to interact and communicate in spoken spanish or english. exclusion criteria: * hiv-positive * cisgender women * transgender women

Keywords: latino/hispanic/latinx men who have sex with men
safety, tolerability and pharmacokinetics of inhaled doses of azd4818 in healthy japanese male volunteers

Conditions: Healthy

Summary: the purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of azd4818 in healthy japanese male volunteers.


Eligibility criteria:
inclusion criteria: * provision of informed consent * body mass index (bmi) between 18.0-27.0 kg/m2 * no clinically relevant abnormal findings exclusion criteria: * acute illness which requires medical intervention * definite or suspected personal history of adverse drug reactions or drug hypersensitivity. * clinical relevant disease or disorder (past or present) * a history of respiratory disorders

Keywords: phase i japan japanese inhalation
using a text-message system to engage depressed adolescents in cognitive-behavioral therapy homework

Conditions: Major Depressive Disorder; Cognitive Behavior Therapy; Text Messaging

Summary: the primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (cbt) for major depressive disorder.

adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (weissman et al 1999). cognitive behavioral therapy (cbt) is an accepted first-line therapy for mild-moderate depression in adolescents. integral to cbt is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (detweiler et al 1999). adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. one method of implementing cbt homework in a manner that is centric to current youth culture is through text messaging. by using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.

Eligibility criteria:
inclusion criteria: * major depressive disorder * own a cellular phone with text messaging capabilities exclusion criteria: * history of psychosis * history of mental retardation * active suicidal ideation or intent

Keywords: depression cbt texting sms
allogenic plasma aliquots in the treatment of ligneous conjunctivitis

Conditions: Ligneous Conjunctivitis, Left Eye

Summary: allogenic plasma aliquots, used as eye drops, will provide a source of plasminogen in the treatment of ligneous conjunctivitis. the investigational product will be available through written request from the sponsor-investigator to canadian blood services, as approved by health canada.

ligneous conjunctivitis is a chronic progressive disorder of the conjunctival mucosa which occurs secondary to plasminogen deficiency. the condition is characterized by thick, fibrous pseudo membranes adherent to the conjunctival surface of the eye lid.the investigational product, allogenic plasma aliquots, is a source of plasminogen. it will be used as eye drops, to treat recurrences of these pseudo membranes by providing the plasminogen required for fibrinolysis. the allogenic plasma aliquots are prepared by canadian blood services. an initial supply of 680 vials was made available through the special access program, upon approval by health canada. through this clinical trial, additional allogenic plasma aliquots will be available when required to treat recurrences of the pseudo membranes. the study has been conditionally approved by local hreb, pending registration with clinicaltrials.gov

Eligibility criteria:
inclusion criteria: * subject diagnosed with ligneous conjunctivitis associated with type 1 plasminogen deficiency exclusion criteria: * subject has concurrent eye disease which prevents use of the investigational drug